Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

Phase 2

Completed

Interventions: Drug: 0.10% VOS
Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)
Drug: 0.20% VOS
Drug: Vehicle Ophthalmic Solution

Brief Summary: A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.

Detailed Description: This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.

Recruitment & Eligibility

Inclusion Criteria

Exclusion criteria:

Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.
Recent or current evidence of infection or inflammation in either eye.
Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.
Have used any investigational drug or device within 30 days prior to Visit 1.
Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.
Have worn contact lenses 24 hours prior to Visit 1.
Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1.
Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
0.10% VOS	0.10% VOS	0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
0.05% Voclosporin Ophthalmic Solution (VOS)	0.05% Voclosporin Ophthalmic Solution (VOS)	0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
0.20% VOS	0.20% VOS	0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)	4 Weeks	Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Eye Dryness	Value at 4 Weeks minus value at baseline	Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥ 60 mm. Eye Dryness Visual Analogue Scale 0-100 mm, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."